510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897045Substantially Equivalent

Bowie-Dick Test Card Catalog Number 008018

Edward Weck, Inc., Research Triangle Pa NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897045 is the FDA 510(k) clearance record for BOWIE-DICK TEST CARD CATALOG NUMBER 008018, a class II device, cleared for Edward Weck, Inc. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show one recall naming K897045.

Clearance record

Decision date
Received
(58 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Edward Weck, Inc. P.O. Box 12600, Research Triangle Pa NC
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260